Inspection Readiness Support

The implementation of the EU Clinical Trials Directive has resulted in a dramatic increase in the number and scope of inspections in Europe. At the same time the US FDA has increased their inspection capacities. In addition, US FDA and EMA and relevant national inspectorates have increased their collaboration, settled on common inspection standards and formalised the exchange of inspection reports.

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In parallel, these agencies have engaged in global capability building and training programs that have resulted in the creation of national inspectorates in Asia, Latin America, Africa and the Middle East. The effects of these regulatory efforts are clear: the number of inspections is steadily increasing - year by year - and in a large multinational company can be as high as 40 – 50 inspections per year. Start-up companies should bear in mind that Health Authority inspections, especially in Europe, are not necessarily linked to a regulatory submission but can occur at any time and in any clinical trial of any phase.

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How can Widler & Schiemann assist you with the Inspection Readiness of your company?Widler & Schiemann have a recognised track record of developing and implementing a process to make an organisation inspection ready. A toolkit has been developed to assist teams and functions to reach an inspection ready state, and a self-assessment tool provides objective evidence of strengths and weaknesses of the organisation in terms of inspection readiness.

Widler & Schiemann will work with your management, experts and process owners to identify inspection readiness gaps, define where necessary effective CAPA plans and oversee their timely implementation. In case of a Health Authority inspection Widler & Schiemann can be brought in as additional resources to support your organisation during the inspection and, if necessary, help with responses to the inspectors.